Gait Speeds and Demands in Chronic Stroke Patients: A Multi-dimensional Investigation

NCT ID: NCT04436536

Last Updated: 2021-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-26

Study Completion Date

2021-12-31

Brief Summary

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This study investigated the effect of treadmill walking training with and without random speed changes in persons in the chronic stage of stroke. It was hypothesized that random speed change group will show less attention and balance demands for speed change in level walking.

Detailed Description

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This study includes chronic stroke patients who will be randomly assigned to blocked or random walking speed change group to receive 30 min per session, 3 sessions per week for 2 weeks' walking training on a treadmill. The outcome measures include gait characteristics under 3 tasks x 3 speed conditions x 2 attention conditions on an obstacle-free walk way. The three tasks are normal walking, narrow based walking and obstacle crossing. The three speed conditions are constant (preferred) speed, speeding up (preferred to maximum speed), and slowing down (maximum to preferred speed). The two attention conditions are none and serial subtraction of 3 during walking. Clinical sensorimotor function assessment, including hand grip strength, plantar sensitivity, stroke rehabilitation assessment of movement and Fugl-Meyer lower extremity motor scale will be conducted for subject characterization.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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training with random speed changes

Walking training on treadmill with random speed changes, that is, random sequence of several different walking speeds

Group Type EXPERIMENTAL

Treadmill walking training with random speed changes

Intervention Type OTHER

Participants were asked to walk in different gait speed randomly on the treadmill (80%, 90%, 100%, 110% and 120% of preferred speed). The training speed would be changed in every 15 seconds in 2-minutes-section. 2 minutes/ section, 10 sections/ day, 3 days/ week, 2 weeks. 1 minute rest time would be held between sections.

training with blocked speed changes

Walking training on treadmill with blocked speed changes, that is a steady progression of faster walking speed.

Group Type ACTIVE_COMPARATOR

Treadmill walking training with blocked speed changes

Intervention Type OTHER

Participants were asked to walk in same gait speed on the treadmill per day (80%, 90%, 100%, 110% and 120% of preferred speed, respectively). 2 minutes/ section, 10 sections/ day, 3 days/ week, 2 weeks. 1 minute rest time would be held between sections.

Interventions

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Treadmill walking training with random speed changes

Participants were asked to walk in different gait speed randomly on the treadmill (80%, 90%, 100%, 110% and 120% of preferred speed). The training speed would be changed in every 15 seconds in 2-minutes-section. 2 minutes/ section, 10 sections/ day, 3 days/ week, 2 weeks. 1 minute rest time would be held between sections.

Intervention Type OTHER

Treadmill walking training with blocked speed changes

Participants were asked to walk in same gait speed on the treadmill per day (80%, 90%, 100%, 110% and 120% of preferred speed, respectively). 2 minutes/ section, 10 sections/ day, 3 days/ week, 2 weeks. 1 minute rest time would be held between sections.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with first stroke for at least 6 months
* Able to walk for at least 20 minutes independently without exhaustion
* Residual gait deficits
* Resting blood pressure is lower than 150/90 mmHg

Exclusion Criteria

* Unable to follow experimental instructions during the process
* Any pain, inflammation, or other neuromuscular or musculoskeletal conditions in the lower limbs that affect walking ability
* Unstable health problems
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tainan Hospital, Ministry of Health and Welfare

OTHER

Sponsor Role collaborator

National Cheng Kung University

OTHER

Sponsor Role lead

Responsible Party

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Sang-I Lin

Professor, Department of Physical Therapy, National Cheng Kung University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lin Sang-I, PhD

Role: STUDY_CHAIR

National Cheng Kung University

Locations

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National Cheng Kung University

Tainan City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Lin Sang-I, PhD

Role: CONTACT

+886-6-235-3535 ext. 5020

Lee Pei-Yun, PhD

Role: CONTACT

+886-6-235-3535 ext. 5936

Facility Contacts

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Lin Sang-I, PhD

Role: primary

+886-6-235-3535 ext. 5020

Other Identifiers

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A-BR-107-101-T

Identifier Type: -

Identifier Source: org_study_id

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